BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNX

    MDR report key: 1772179 · Received July 21, 2010

    Report

    Report Number
    1772179
    Event Type
    Malfunction
    Date Received
    July 21, 2010
    Date of Event
    April 27, 2010
    Report Date
    July 21, 2010
    Manufacturer
    ACCESSCLOSURE
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    AFTER THE PATIENT HAD UNDERGONE THE PROCEDURE, THE DOCTOR DETERMINED SHE WAS A CANDIDATE FOR THE MYNX CLOSURE DEVICE. HE FOLLOWED APPROPRIATE PROCEDURES TO MAKE THIS DETERMINATION AND APPROPRIATE TECHNIQUE IN DEPLOYING THE DEVICE. THE MYNX WAS DEPLOYED AT 1051 AND BY 1055 THE PATIENT HAD DEVELOPED A SIGNIFICANT HEMATOMA. MANUAL PRESSURE WAS APPLIED AND AT 1105 A FEMOSTOP WAS APPLIED TO OBTAIN HEMOSTASIS. THE PATIENT WAS TRANSPORTED TO CCU FOR OBSERVATION. FURTHER TESTING DEMONSTRATED THE PATIENT HAD A LEFT GROIN PSEUDOANEURYSM WHICH WAS TREATED AT BEDSIDE WITH A THROMBIN INJECTION. THE PATIENT WAS DISCHARGED TO HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX DEVICE, HEMOSTASIS, VASCULAR MGB ACCESSCLOSURE * F00934502

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR